5 American College of Physician Executives Susan M. Lapenta, JD Mrs. Lapenta is a partner in the law firm of Horty, Springer & Mattern, P.C. of Pittsburgh, Pennsylvania, which specializes in the practice of health care law. The firm represents institutional providers, such as hospitals, multi-hospital systems and health maintenance organizations nationwide. Ms. Lapenta is a contributor to the ACTION KIT publications: ACTION KIT for Hospital Law, ACTION KIT for Hospital Trustees, and The Health Law Express. Ms. Lapenta has worked extensively with hospitals and their medical staffs on peer review investigations and hearings. She has also assisted medical staffs in the revision of bylaws and related projects. Additionally, Ms. Lapenta has served as counsel in litigation stemming from credentialing decisions, including the defense of antitrust claims. Ms. Lapenta is on the faculty of the American College of Physician Executives and the American College of Obstetricians and Gynecologists. Ms. Lapenta received her Bachelor of Arts degree from West Virginia University in 1981, and her Juris Doctor degree from the University of Pittsburgh School of Law in She was a member of the staff and served as the Managing Editor of the University of Pittsburgh Law Review. Upon graduating from law school, Ms. Lapenta worked as a law clerk for U. S. District Court Judge Glenn E. Mencer. She is a member of the Allegheny County, Pennsylvania and American Bar Associations.

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7 American College of Physician Executives Henry M. Casale, JD Mr. Casale received a B.S. 1979, J.D. 1984, University of Pittsburgh. Mr. Casale is a partner with the law firm of Horty, Springer & Mattern, P.C. of Pittsburgh, Pennsylvania and is a licensed pharmacist. He has served on the faculty of seminars sponsored by the firm which authors Horty Springer publications including The Health Law Express, as well as meetings and seminars sponsored by numerous hospital, managed care, legal and physician organizations, including the American Health Lawyers Association, the American College of Physician Executives, the Pennsylvania Bar Institute, the Society of Healthcare Attorneys of Western Pennsylvania and the American Association of Health Plans (formerly the Group Health Association). He also co-authored, with Eric W. Springer, Hospitals and the Disruptive Health Care Practitioner: Is the Inability to Work With Others Enough to Warrant Exclusion?, 24 Duq. L.R.377 (1985). He has served as a member of the Board of Directors and as the President and Vice-President of the Society of Healthcare Attorneys of Western Pennsylvania. He has also served as a member of the Health Law Section of the Allegheny County Bar Association. 5/03

13 The Law The Law Overview of The Law Constitution Statutes Regulations Common Law Constitution The system of fundamental laws and principles of a government. (Appendix A) Constitution Allocates power among branches of federal government Allocates power between state and federal government Creates rights in individuals vis-à-vis the government Article I The federal constitution was adopted d in It consists of 7 articles and 27 amendments. The last amendment was ratified in Establishes the legislative branch of the government, including the House of Representatives and the Senate. 1

14 The Law Legislative branch has power to: Regulate commerce Coin money Declare war Create courts inferior to Supreme Court Article II Establishes the executive branch of the government, including the positions of President and Vice President. Article III Foundation of electoral college contained in Article II. Establishes the judicial branch of the government, including the Supreme Court. The Federal Judicial Circuits Federal courts are courts of limited jurisdiction

15 The Law First Amendment Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof, or abridging the freedom of speech, or the press. Issues raised under First Amendment: Pornography School prayer Flag burning Right to refuse medical treatment Sixth Amendment In all criminal prosecutions, the accused shall enjoy the right to a speedy and public trial, by an impartial jury and to have the assistance of counsel for his defense. Seventh Amendment In suits at common law, where the value in controversy shall exceed twenty dollars, the right to trial by jury shall be preserved. Fourteenth Amendment Claims for equitable relief do not trigger right to jury. Nor shall any State deprive any person of life, liberty, or property, without due process of law. 3

16 The Law Right to Privacy Challenges to exclusion from medical staff have been brought under Fourteenth Amendment. A subtle blend of several of the most tf fundamental rights established by the Constitution. Griswold v. Conn (U.S. Ct. 1965) Court struck down state law banning prescription of contraceptives. Right to Privacy Abortion Access to contraceptives Refusal of medical treatment Statute A law passed by a legislative body and set forth in a formal document. Statute examples: Sherman Antitrust Act Fraud and Abuse HCQIA EMTALA ERISA Stark 4

17 The Law Statute examples: (cont d.) Medical Practice Act Informed Consent Patient Self-Determination Act Regulation Rules promulgated by an administrative agency pursuant to authority set forth in the enabling statute. Common Law Law established through the decisions of courts. Common Law examples: Informed consent Negligent credentialing 5

21 The Law Cost Quality Activity Practice of Medicine Licensed in all states Limited and temporary privilege extended to properly trained individuals Not a constitutionally-guaranteed right Activity Practice of Medicine What activities are included in the Practice of Medicine will vary from state to state QA decisions? CAM? Site where activity is performed usually not licensed Activity Practice of Medicine If a physician expands the scope of services in his/her office, may need to become licensed Corporate Practice of Medicine Who May Employ a Physician to Provide Professional Services Enforced differently in different states Texas Medical Practice Act Tennessee State statute Pa./Ill. Common Law And in some states the doctrine does not exist. 2

22 The Law Doctrine usually does not apply to administrative services MCO usually exempt by state statute Where It Exists, the Corporate Practice of Medicine Should Be Considered When: Employing physicians A physician is forming a joint venture involving a non-physician Entering into a practice management arrangement with a for-profit management company Is the Purpose of the Doctrine: 1. The protection of physicians from competition? or 2. The protection of patients? Technology is making it difficult for medicine to remain a local activity Telemedicine 3

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24 TAB Lecture 4

25 Trends in Liability Trends in Liability and Tips on How To Avoid It! Respondeat Superior Apparent Agency Negligent Credentialing Antitrust Civil Rights Claims Trends in Liability Charitable Immunity Doctrine No Liability Flagiello v. The Pennsylvania Hospital (Pa. 1965) Non-liability is an anachronism. It is a plodding ox on a highway h built for high speed vehicles. Elements of Negligence Immunity tends to foster neglect while liability tends to induce care and caution. Duty Breach Injury Causation 1

28 Trends in Liability Tip Speak No Evil has its cost. Kadlec Medical Center v. Lakeview Anesthesia Assoc. (E.D. La. 2005) Lakeview Anesthesia Associates As we have discussed on several occasions, March 27, 2001 you have reported to work in an impaired physical, Dear mental Dr. Berry: and emotional state. Your As we have discussed on several occasions, you have impaired condition has prevented you from reported to work in an impaired physical, mental and emotional state. Your impaired condition has properly performing your duties and puts our prevented you from properly performing your duties and puts our patients at significant risk. patients at significant risk. Effective March 13, 2001, your employment with Lakeview Anesthesia Associates is terminated. Sincerely, Lakeview Anesthesia Associates March 27, 2001 Dear Dr. Berry: As we have discussed on several occasions, you have reported to work in an impaired physical, mental and emotional state. Your impaired condition has prevented you from properly performing your duties and puts our patients at significant risk. Effective March 13, 2001 your employment with Lakeview Effective March 13, Anesthesia 2001, your employment Associates with is Lakeview Anesthesia Associates is terminated. terminated. Sincerely, Lakeview Anesthesia Associates Lakeview Anesthesia Associates Lakeview Regional Medical Center October 26, 2001 To: Kadlec Medical Center Dr. Berry was on the Active Staff in the field of anesthesiology at LRMC from March 4, 1997 to September 4, Lakeview Regional Medical Center Dr. Berry was on the Active Staff in the field of anesthesiology at October 26, 2001 LRMC To: Kadlec from Medical March Center 4, 1997 to Dr. Berry was on the Active Staff in the September field of anesthesiology 4, at LRMC from March 4, 1997 to September 4, No further information can be provided due to the large volume of inquiries received in the office. No further information can be provided due to the large volume of inquiries received in the office. Sincerely, Chief Executive Officer Sincerely, Chief Executive Officer 4

29 Trends in Liability Lakeview Regional Medical Center October 26, 2001 To: Kadlec Medical Center Dr. Berry was on the Active Staff in the No further field of anesthesiology information LRMC can from be March 4, 1997 September 4, provided due to the large volume No further of inquiries information can received be provided in due to the large volume of inquiries the office. received in the office. Sincerely, Chief Executive Officer Lakeview Anesthesia Associates Fall 2001 To: Kadlec Medical Center Dr. Berry is an excellent physician. He would be an asset to any anesthesia service. Sincerely, Lakeview Anesthesia Associates Lakeview Anesthesia Associates Fall 2001 I have worked with Dr. Berry for To: Kadlec Medical Center four years. He is an excellent physician Dr. Berry and is an will excellent be physician. an asset to any anesthesia service. I Sincerely, recommend him highly. Lakeview Anesthesia Associates Kadlec settles lawsuit brought by patient s family for $7.5 million Jury awarded: Kadlec Medical Center v. Lakeview Anesthesia Associates (5 th Cir. 2008) $2 million against the Medical Center $2 million against members of anesthesia group The Court found that t response from Lakeview Medical Center was not misleading. 5

32 Trends in Liability Tip Tip Keep physicians with economic interest out of decision-making role. Board must make final decision. Civil Rights Claims ADEA ADA Title VII prohibits discrimination based on race, religion, sex, national origin With the exception of the ADA, all of these claims require employment relationship. Tip Civil il rights statutes t t are liberally ll interpreted and offer broad protection for employees. Create and maintain contemporaneous record of concerns. 8

35 Fraud & Abuse Medicare Antikickback Statute In return for referring an individual, or recommending, or arranging for purchase, lease or ordering Item or service paid for in whole or in part by a federal health care program Medicare Antikickback Statute Fine not to exceed $25,000; or Imprisonment not to exceed 5 years; or Both Violation of Antikickback Statute can also result in: a. OIG Administrative Proceedings to impose civil money penalties pursuant to 1128(a)(7) of the SSA 1. Ex CIA involving William Hendrickson (6/8/05) b. Exclusion from Federal Health Care pursuant to 1128(b)(7) of the SSA c. False claims liability/qui tam suits? d. Violation of state law Statutory Exceptions Employment Discounts Group purchasing organization Statutory Exceptions Safe harbors Requires a written agreement Term of at least 1 year Specify services/equipment Total compensation must be set in advance, FMV and not take into account volume or value of referrals so fee-for-service payment will not qualify for safe harbor protection, but is not per se unlawful *Voluntary When outside of safe harbor, close counts *Advisory Opinion process e. Other (Non-Fraud & Abuse) Concerns 1. IRS Revocation of tax exemption 2. Private cause of action Polk County Memorial Hospital v. Peters 2

36 Fraud & Abuse English Translation 1. Employment issues are unique and must be handled separately 2. Safe harbors are safe, but not mandatory 3. Referral decisions should be made based on the needs of the patient 4. You cannot pay for referrals 5. But may have economic relationship with entities to which the provider refers English Translation (cont d.) 6. DOJ enforces the criminal law in Federal Court 7. OIG may use an administrative proceeding to impose monetary penalty 8. Both will result in exclusion 9. Don t forget about state laws 10. Compliance with Stark Exception irrelevant (See OIG Advisory Opinions and 04-17) Tip: In each instance, the parties intent is key to outcome. So document benefits you hope to achieve. Tip: Do pay fair market value. Do not pay for referrals. Tip: You cannot buy loyalty. You cannot even rent it. U.S. v. Anderson, 1998 Criminal prosecution of physicians, hospital executives, and two lawyers 3

38 Fraud & Abuse Inpatient/Outpatient Hospital Services Rx DHS Home Health Prosthetics & orthotics Nuclear Medicine Enteral & Parenteral Nutrient DME Clinical Lab Radiology PT, OT Radiation Therapy DHS Entity Bill Medicare (for DHS) How Stark Works Referral for DHS $$$ Relationship Exception Or family member If physician refers Medicare/Medicaid beneficiary to the entity for DHS, the entity may not submit a bill to Medicare or Medicaid for DHS If bill is submitted to Medicare/Medicaid, the claim will not be paid and any payment made must be refunded Administrative CMP up to $15,000/claim Claim may also be considered to be a false civil money penalty claim + exclusion from Medicare Also subject to qui tam suits Stark liability is aimed at the DHS entity, but referring physician may be sanctioned with the imposition of CMPs for knowing violations of the Act. If Stark applies, must satisfy at least one exception. Evolution of Stark Phase III Phase I Phase II Stark II Stark I

39 Fraud & Abuse New Stark Phase 4 Regulations August 19, 2008 Stark 4! Final revisions to Stark regulations published as part of the 2009 Inpatient Hospital Prospective Payment Rules Stark Phase 4 Regulations Effective date generally October 1, 2008 Delayed effective date October 1, 2009 Percentage of compensation based rental arrangements Per use or per click space or equipment rental arrangements Definition of entity and effect on Under Arrangements Joint Ventures Physician Investor The Classic Joint Venture Due to Stark, there is a limited number of such investment opportunities for physicians - Used where Newco does not provide a DHS (Ex., ASC) NEWCO 6

41 Fraud & Abuse Exceptions applicable to physician investment in entities that provide DHS (cont d): Investment must be in entire hospital Physician investment in any specialty hospitals (both urban and rural) was prohibited during 18 month moratorium that began 12/8/03. Grandfathering provision, ii but very limited it Moratorium ended on June 8, 2005 Several bills that would have affected this exception were passed by Congress, but vetoed by President Bush. Due to projected savings, likely to arise in the future, but unclear what their fate will be under President Obama. Exceptions applicable to physician investment in entities that provide DHS: 2. Exception for investment in Rural Providers of DHS (But beware of anti-kickback issues!) Exceptions applicable to physician investment in entities that provide DHS (cont d): 3. In office ancillary services very fact specific Have been limited significantly by the Medicare anti mark up rules adopted as part of 2009 Physician Fee Schedule Also consider: OIG may object (see Advisory Opinion and 04 17) Private insurance may not have same rules (e.g., Highmark BC/BS Professional Provider Privileging Guidelines) State law may be more restrictive 8

42 Fraud & Abuse Exceptions related to compensation arrangements (contracts) Need to characterize the specific compensation arrangement at issue. 1. Employment (a) Group practice (b) Others 2. Personal Services Agreement (i.e., Independent Contractor) (a) Term of at least 1 year (b) Less than 1 year (c) Who is the other party to the Agreement, a Physician or a Physician Organization Stand in the Shoes Physician deemed to have same compensation arrangements as his or her physician organization Stand in the Shoes Applies only to physicians who are owners or investors in the Physician Organization. 9

43 Fraud & Abuse Stand in the Shoes DHS Entity $ Physician Organization $ Physician owner/investor Physician Stand in the Shoes DHS Entity $ Physician owner/investor If Physicians are employees of the Physician Organization: DHS Entity or, if you wish DHS Entity Physician Organization Use indirect compensation rule analysis Physician Employee Physician Employee Stand in the Shoes Does not apply to arrangements meeting Indirect Compensation Exception for the original and current term if in effect on 9/5/ Lease of space or equipment 10

44 Fraud & Abuse Phase 4 Regulations Prohibit Per Click Leases Space and equipment leases may not include unit of service payments Applies regardless of whether the physician or the DHS entity is the lessor Applies to both diagnostic and therapeutic equipment Does not prohibit per diem lease Delayed Effective Date until October 1, 2009 Phase 4 Regulations Prohibit Percentage-Based Rental Arrangements Applies to space and equipment to leases only Cannot base rent on percentage of physician s s revenue Does not prohibit pro rata rent adjustments Delayed Effective Date until October 1, 2009 Percentage billing and other non-rental compensation arrangements still permitted (i.e., Service Agreements unaffected) 4. Other exceptions for practice acquisitions: recruitment t agreements and retention arrangements, etc. Again, Employment Agreements are unique and unique rules apply. Common Elements to Non- Employment-Related Exceptions: Leases and personal services agreements must be in writing and must have a term of at least one year. But may be able to terminate without cause. Common Elements Fair Market Value Key to All Stark Exceptions a. Document b. Benchmark where available, but third party appraisal not always necessary 11

45 Fraud & Abuse Common Elements Fair Market Value Key to All Stark Exceptions c. Commercially reasonable even if no referrals were made between the parties d. Amount cannot be based on volume or value of referral to entity that provides a designated health service e. Can pay on a per service basis. But (as of 10/1/09) can no longer pay space/equipment rental on a per click basis Common Elements Fair Market Value Key to All Stark Exceptions f. What about opportunity cost valuation? g. Pay attention to details Form specific law where even amendments to compensation term are permitted only if set in advance. Alternative Criteria Technical violations of Stark may be corrected if: 1. arrangement satisfies all but signature requirements 2. arrangement brought into compliance within applicable time period 3. time period depends on whether failure to obtain signature is inadvertent (90 days) or not inadvertent (30 days) 4. used only once/three years/physician Alternative Criteria Permits correction, but remember: 1. not intended to be used to back-date agreement 2. if fail to obtain signatures within required time, Period of Disallowance begins when the compensation arrangement begins 3. no requirement to self-disclose Period of Disallowance: How long is DHS Entity prohibited from billing Medicare for referrals from a physician with a tainted financial relationship? 12

47 Fraud & Abuse Medicare physician incentive plan (PIP) rules are intended to prevent incentives to withhold care: Hospital PIP rules Managed care PIP rules Gainsharing or cost sharing arrangements Examples July 8, 1999 OIG Special Advisory Thought to have all but killed most gainsharing arrangements involving Medicare patients. (Appendix M) But since 2001 limited cost sharing arrangements have been permitted by a number of OIG Advisory Opinions. But questions under Stark persist. (Appendix M) What is on the Horizon? New Gainsharing and Pay-for- Performance Rules proposed on But never adopted in final form. In the 2009 Physician Fee Schedule, CMS asked for comments on 55 aspects of these rules. One should also consider the practical problems with implementation of the transaction. 14

48 Fraud & Abuse Laws Aimed at Preventing Remuneration to a Beneficiary Intended to Affect Beneficiary Choice III. Laws Aimed at Preventing Remuneration to a Beneficiary Intended to Affect Beneficiary Choice Section 231(h) of HIPAA amended the Civil Money Penalty Law to prohibit any payment to a beneficiary to induce the beneficiary to receive services from a provider (codified at 42 U.S.C. 1128(a)(5)) Limited exceptions, but may provide preventive care and free mission related care Laws Aimed at Preventing Remuneration to a Beneficiary Intended to Affect Beneficiary Choice Subject of several Advisory Opinions Also check kstate t Laws (Appendix R) 15

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50 TAB Lecture 6

51 False Claims Act Violations and Corporate Compliance False Claims Act Violations 31 U.S.C The Players 1) Department of Justice (DOJ) enforces civil and criminal law 2) Office of Inspector General (OIG) cannot go to court has authority to administratively exclude a provider from a federal health care program The Players 3) Qui Tam Relators private party must be original source of admissible information case brought in federal court DOJ may join or may decline receives a % of recovery Violation occurs when a person knowingly presents false or fraudulent claims. Reckless disregard of the truth is sufficient to establish knowing violation do not need to prove specific intent. However, innocent mistakes, even negligence, do not constitute a violation of the False Claims Act. 1

53 False Claims Act Violations and Corporate Compliance Tip: Best means of complying with False Claims Act is an effective e compliance program. Corporate Compliance (Appendix L) The OIG has told health care providers what it thinks they should be doing by: Publishing a model Compliance Guidance for various providers including physicians OIG has published Final Supplemental Compliance Guidance for Hospitals on January 31, 2005 Result: Many providers have adopted, or are in the process of adopting, a corporate compliance process (Appendix P) September 25, 2000 OIG published its Final Compliance Program Guidance for Individual and Small llgroup Physician i Practices OIG believes that the majority of physicians are honest. However, all health care providers have a duty to ensure that the claims submitted to Federal Health Plans are true and accurate. (Appendix P) 3

PURPOSE This policy complies with requirements under the Deficit Reduction Act of 2005 and other federal and state fraud and abuse laws. It provides guidance on activities that could result in incidents

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1. PURPOSE CHAMPAIGN COUNTY NURSING HOME SUMMARY OF ANTI-FRAUD AND ABUSE POLICIES Champaign County Nursing Home ( CCNH ) has established anti-fraud and abuse policies to prevent fraud, waste, and abuse

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